This is interesting because based on the lecture, I thought that ISO 13485 was the medical device ISO standard, meaning that USA also follows this standard. I believe that Europe also has their version of ISO 14971 and it is EN ISO 14971. However, I believe that the countries still utilize ISO 13485 because it assumes that some sort of risk management analysis was completed and this doesn't limit them strictly to ISO 14971. Since this is considered a consensus standard on the USA side and it is also assumed to be followed in ISO 13485, this would be sufficient for Europe and other countries to follow. As mentioned in the lecture, other countries like Canada and Japan also follow this same path since the consensus standard tag seems to be a strong one. I think Europe finds the ISO 14971 standard enough and has its own version as well, but they have actually accepted ISO 13485 and this has the assumption for the risk management process that essentially serves the same purpose. 

ISO 13485 is functionally the same as ISO 14971, however there is an additional requirement on following EU MDR (European Union Medical Device Regulations). EU MDR does have some significant differences from the regulations dictated by the FDA. One important one for medical devices is the disclosure of CoCr (cobalt chrome) in medical devices. CoCr has a lot of applications in medical devices, especially in joint replacement. In order to sell products in the EU, all of the devices must have additional marking and warnings in their respective IFU (instructions for use) documents. Apparently, this was based on some research that was accepted by the EU regulatory bodies and was not accepted by the FDA. However, that may not be the case as I had heard this information from someone and did not confirm that was the case via research. Anyway, EU MDR has a different ISO standard because it directly point out some stricter regulations that what is already in ISO 14971.

Following the responses made above, ISO 14971 is an internationally recognized standard for risk assessment that both the US and EU use. ISO 13845 is a specific type of risk assessment standard that highlights the requirements for quality management systems for companies that are involved in the design, production, installation, and servicing of medical devices. ISO 13845 references ISO 14971 because the latter is a big umbrella that its subdivision ISOs could use as a reference. In other words, ISO 13845 was created for a specific type of medical device development process that ISO 14971 was not specific enough about. 

ISO 13485 and ISO 14971 serve distinct purposes within the context of medical devices, and their relationship is not necessarily a reflection of insufficiency in ISO 14971. Instead, it stems from the different focuses and requirements of each standard.

1. ISO 14971 - Risk Management:

   • ISO 14971 is an international standard specifically focused on risk management for medical devices. It provides a systematic approach to identifying, analyzing, evaluating, and controlling risks associated with medical devices throughout their lifecycle.
   • While it is a crucial standard for ensuring the safety and effectiveness of medical devices, it primarily addresses risk management and may not cover all aspects related to the broader quality management system.

2. ISO 13485 - Quality Management System for Medical Devices:

   • ISO 13485 is a standard that outlines the requirements for a comprehensive quality management system (QMS) for medical devices. It encompasses various aspects, including design and development, production, storage, distribution, and post-market activities.
   • ISO 13485 references ISO 14971 in the context of risk management, acknowledging the importance of ISO 14971's specialized focus on this critical aspect.

Reasons for Elaboration in ISO 13485:

• Comprehensive Quality Management: ISO 13485 addresses a broader range of requirements beyond risk management. It is concerned with establishing and maintaining a robust QMS that ensures the consistent quality of medical devices throughout their lifecycle.
• Regulatory Alignment: ISO 13485 is aligned with regulatory requirements in Europe (and in many other regions) for demonstrating compliance with quality standards. Therefore, ISO 13485 includes references to relevant standards like ISO 14971 to ensure a holistic approach to quality management.

Necessity:

• The elaboration in ISO 13485 does not necessarily imply inadequacy in ISO 14971. Instead, it reflects the need for a comprehensive quality management system that encompasses risk management among other crucial elements.
• Europe, like other regions, recognizes the importance of both risk management and broader quality management principles in the development and maintenance of safe and effective medical devices.

In summary, ISO 14971 and ISO 13485 play complementary roles, with ISO 13485 providing a comprehensive framework for a QMS, including risk management, and referencing ISO 14971 for the specialized aspect of risk management. This approach ensures a well-rounded approach to quality and safety in the development and manufacturing of medical devices.